BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEMS

    MDR report key: 2123936 · Received June 14, 2011

    Report

    Report Number
    2050012-2011-02303
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 17, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMEN WAS SERUM. QC ON THE DAY OF THE EVENT WAS WITHIN LAB-ESTABLISHED RANGES, BUT THE RANGES ARE TOO WIDE AND THE QC DID EXHIBIT RECOVERY THAT WAS TOO LOW. A FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND FOUND NO ISSUES. AS A PREVENTIVE MEASURE, THE FSE REPLACED THE ELECTROLYTE INJECTION CUP (EIC) VALVES. ISE HEALTH CHECKS PASSED SPECIFICATIONS. ALTHOUGH THE CUSTOMER BELIEVES THE ISSUE WAS RELATED TO LABORATORY TEMPERATURE AT THE TIME OF EVENT, A CLEAR ROOT CAUSE FOR THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING FALSELY LOW SODIUM (NA) RESULTS GENERATED BY THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. RESULTS WERE REPORTED OUT OF THE LAB. IT IS UNKNOWN HOW MANY PATIENT RESULTS WERE AFFECTED. THE CUSTOMER ONLY PROVIDED THE REPORT FROM ONE PATIENT. THE SAMPLE WAS REPEATED WITH HIGHER RESULTS, AND THE RESULTS WERE AMENDED. THE CUSTOMER ONLY REPEATED NA, IT IS UNKNOWN IF OTHER ION SELECTIVE ELECTRODE (ISE) ANALYTES WERE AFFECTED. PATIENT TREATMENT WAS NOT INITIATED OR WITHHELD BASED UPON THE LOW RESULTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEMS CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 600I NA

    Patients

    Seq Age Sex Outcome Treatment
    1